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Terminated

smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116 Bone plates and bone screws from the EVOS Mini-Fragment Plating System are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.

FDA Recall Z-0408-2018 · Posted None

Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeHRS
Date Initiated2017-11-29
Date Terminated2020-09-01
Product Quantity12

Reason for Recall

One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.

Firm Action

Smith & Nephew Inc. initiated its recall by email on November 29, 2017. The consignee was directed to return the recalled product. For further questions, please call (901) 396-2121.

Root Cause

Employee error

Distribution Pattern

US Distribution to the state of OR, and Internationally to Colombia.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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